Edwards Lifesciences

This trial tests a new device called the Edwards SAPIEN M3 System for people with severe mitral regurgitation, a condition where a heart valve leaks blood backward. The device is placed using a thin tube threaded through blood vessels, avoiding open-heart surgery. The study inclu…

This study tests a special heart valve for children aged 1.5 to 16 years with congenital heart disease who need a pulmonary valve replacement. The valve can be expanded after implant to match the child's growth, potentially avoiding multiple surgeries. Researchers will check safe…

This trial tests a device called the Edwards PASCAL system, which is used to repair a leaky tricuspid valve in the heart without open-heart surgery. The study includes 300 people with severe tricuspid regurgitation who are candidates for this procedure. Researchers are checking h…

This study compares two devices—the Edwards PASCAL and the Abbott MitraClip—that repair leaky mitral heart valves without open-heart surgery. About 1,200 people with severe mitral regurgitation who are too high-risk for surgery are being randomly assigned to one device. The goal …

This study tests a device called the Edwards APTURE shunt, which is implanted in the heart to create a small opening that lowers pressure. The goal is to see if it can improve symptoms and quality of life for 100 people with a certain type of heart failure. Half of the participan…

This study tracks how well the MITRIS RESILIA mitral valve works in real-world patients who need a new mitral valve due to narrowing or leakage. About 504 adults having valve replacement surgery will be followed for safety and performance, including valve function and major heart…

This study is testing a device called the Edwards Cardioband FIT, which is used to repair the tricuspid valve in people with tricuspid regurgitation (a leaky heart valve). The device is delivered through a catheter, avoiding open-heart surgery. The trial includes 75 participants …

This study is testing a new device called the Edwards EVOQUE system, which replaces the tricuspid valve using a thin tube (catheter) instead of open-heart surgery. The trial includes 228 people with moderate or severe tricuspid regurgitation who still have symptoms despite medica…

This study is testing a newer version of a heart valve device, called the SAPIEN 3 Ultra, in 200 people with severe aortic stenosis (a narrowed heart valve). The valve is implanted through a tube in an artery, avoiding open-heart surgery. Researchers are checking how well the val…

This study tests a new device called the Edwards EVOQUE eos mitral valve replacement system. It is for people with a leaky mitral valve who are too high-risk for open-heart surgery. The study will check if the device is safe and works well by looking at complications, heart funct…

This study follows 255 Chinese patients who received the INSPIRIS RESILIA aortic valve to see how safe and well it works over several years. Researchers track problems like valve failure, blood clots, bleeding, and the need for another surgery. The goal is to confirm the valve's …

This study tests a new device called EVOQUE that replaces the tricuspid valve in people with severe leakage (tricuspid regurgitation). The goal is to see if it is safe and can reduce leakage, improve symptoms, and enhance quality of life compared to standard medical therapy alone…

This study is testing a new heart valve, called the SAPIEN 3, in 150 people with congenital heart defects whose existing heart valves are not working properly. The valve is placed using a thin tube (catheter) through a blood vessel, avoiding open-heart surgery. The goal is to see…

This study is testing a device called the APTURE shunt, which is implanted in the heart to create a small passage that may help relieve pressure. It involves 45 people with symptomatic heart failure who are already on standard medications. The goal is to see if the device is safe…

This study tests a new, less invasive heart valve (SAPIEN 3) for people with severe aortic stenosis who are at low risk for standard surgery. About 1,000 participants will be randomly assigned to get the new valve or traditional open-heart surgery. The goal is to see if the new v…

This study is testing a new device called the CENTERA THV, which is a replacement heart valve that can be placed without open-heart surgery. It is for people with severe aortic stenosis (a narrowed heart valve) who are at intermediate risk for surgery. The study will monitor safe…

This study tests a less invasive way to replace a failing mitral valve in the heart. About 53 people who already have a surgical valve that is not working well will receive a new valve placed inside the old one using a thin tube. The goal is to see if this procedure is safe and h…

This study looks at a new device to fix leaky pulmonary valves in people born with heart defects. About 150 people will get the Edwards SAPIEN 3 valve placed inside a special stent. The goal is to see if the valve works well and stays in place without major problems.

This study tests a new device (Alterra Prestent) used with a replacement heart valve (SAPIEN 3) to fix a leaky pulmonary valve in people born with heart defects. About 86 participants with moderate or severe leakage will get the device through a tube in a blood vessel, avoiding o…

This early study tests a device that creates a small opening between the upper chambers of the heart to relieve pressure in people with symptomatic heart failure. The study includes 71 participants and focuses on safety and whether the device works as intended. It is not a cure b…

This study follows 50 people who previously received an INSPIRIS RESILIA aortic valve and now need a valve-in-valve procedure because their original valve is not working well. Researchers will track complications like death, stroke, bleeding, and valve movement, as well as how we…